Sanofi R&D head flags new eczema drug as start of something big

PARIS, March 6 (Reuters) - Sanofi has struggled with a reputation as a laggard in finding new drugs but its global research chief believes the imminent approval of a game-changing eczema medicine signals a new era for the French company.

Dupilumab has impressed doctors in a series of clinical trials over the past year and is widely expected to win a U.S. green light by the March 29 action date set by the Food and Drug Administration.

Once approved, it will be sold as Dupixent and consensus analyst forecasts already point to annual sales of more than $4 billion by 2022, according to Thomson Reuters data.

In an interview with Reuters, Elias Zerhouni said the antibody drug represented more than a single-product success.

"Dupilumab is an illustration of something more profound, which is really the emergence of the new science and portfolio at Sanofi," he said.

The Algerian-born former head of the U.S. National Institutes of Health, who joined Sanofi in 2011, sees dupilumab as the "prototype of future medicine", given its ability to target two disease pathways at once.

Developed with long-time partner Regeneron Pharmaceuticals , dupilumab inhibits two proteins involved in the body's immune response, known as IL-4 and IL-13, giving it an unusually wide range of potential uses.

Such medicines may offer a one-stop-shop for a series of complex diseases, Zerhouni said, adding that dupilumab alone could help fight 14 different disorders, from eczema and asthma to food allergy.

"Dupilumab is a pipeline in a single drug," he said. "It's a game-changing, life-changing drug."

Zerhouni said his whole R&amp;D department was now inspired by this "smarter approach".

"The evolution of science is telling us that we will have to address multiple pathways at once in the future, but do it in a way that is also cost-effective," he said.

Sanofi is now racing to develop other "multi-targeting" drugs.

Another so-called bi-specific antibody for IL-4 and IL-13 is now in mid-stage Phase II clinical testing for pulmonary fibrosis, a deadly condition in which the tiny air sacs in the lungs become damaged and scarred.

Zerhouni described this ratio as being in the "lower tier, mid tier" of the industry but confirmed spending would rise to 6 billion in 2020, in line with a long-term strategic plan.

The pharmaceuticals group badly needs to score some high-profile wins on the new drug front to offset flagging sales in its big diabetes business, where increasing competition and pressure on prices has hit sales and profits.

One option to jump-start the new drug line-up would be to acquire a smaller biotech company with promising assets, and some investors have expressed frustration at its failed attempts to clinch a significant transaction.

That has increased the pressure to make dupilumab a success, especially as analysts have already pencilled in some pretty big numbers for its future sales.

In contrast to the hesitant start for Sanofi's recent new injectable cholesterol drug Praluent, the prospects for dupilumab are arguably more favourable, given its unprecedented ability to clear skin lesions in eczema.

What is more, Sanofi and Regeneron are comfortably ahead of rivals in the race to treat serious atopic dermatitis or eczema with such modern biologic drugs.

Complex biologic drugs, produced in living cells, are at the forefront of many disease areas and now account for two thirds of Sanofi's pipeline of experimental medicines, Zerhouni said.

The French company and Lonza last week unveiled a 270 million euros ($285 million) investment in a new large-scale biologics facility that will be located in Visp, Switzerland, to increase production.

Biologic drugs are certainly effective but they are also more expensive than traditional products, which some analysts say will pose a challenge for Sanofi as it seeks to persuade healthcare providers to pay for dupilumab. ($1 = 0.9446 euros) (Additional reporting by Ben Hirschler; editing by Susan Thomas)